Phase I/II, randomized, double-blind, placebo-controlled, dosage selection (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 mL) study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants.

Shantha Biotechnics Limited, Hyderabad0 sites90 target enrollmentTBD

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Shantha Biotechnics Limited, Hyderabad
Enrollment: 90
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

Shantha Biotechnics Limited, Hyderabad

Eligibility Criteria

Inclusion Criteria

•Healthy infants 6\-8 weeks of age at time of enrollment of either sex;
•\- Born after a gestational period of 36\-42 weeks with birth weight more than equal to 2 kgs
•\- Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
•\- Parent or guardian available for the entire period of the study and reachable by study staff for post\-vaccination follow\-up.

Exclusion Criteria

•\- History of congenital abdominal disorders, intussusception, or abdominal surgery;
•\- Known or suspected impairment of immunological function;
•\- Known hypersensitivity to any component of the rotavirus vaccine;
•\- Prior receipt of any rotavirus vaccine;
•\- Fever, with axillary temperature more than or equal to 38\.1oC (more than or equall to 100\.5oF); measured by study staff.
•\- History of known rotavirus disease, chronic diarrhea, or failure to thrive;
•\- Baseline level of ALT or AST \>2\.5 times the upper limit of normal;
•\- Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
•\- Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study);
•\- Infants residing in a household with an immuno\-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin?s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long\-term systemic corticosteroids);

Outcomes

Primary Outcomes

Not specified

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